On March 19, 2025 Akebia Therapeutics, Inc. ("Akebia") (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported the pricing of its underwritten public offering (the "Offering") of 25,000,000 shares of its common stock at a public offering price of $2.00 per share (Press release, Akebia, MAR 19, 2025, View Source [SID1234651306]). All shares are being offered by Akebia. The gross proceeds to Akebia from the Offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be $50.0 million. In addition, Akebia has granted the underwriters a 30-day option to purchase up to 3,750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The Offering is expected to close on March 21, 2025, subject to the satisfaction of customary closing conditions.

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Leerink Partners and Piper Sandler & Co. are acting as joint bookrunning managers for the Offering. BTIG, LLC is acting as lead manager and H.C. Wainwright & Co. is acting as co-manager for the Offering.

The shares are being offered by Akebia pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on September 3, 2024 and declared effective by the SEC on September 12, 2024.

The Offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the Offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the Offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800)-808-7525, ext. 6105, or by email at [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at (800)-747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 19, 2025 TwoStep Therapeutics, a biotechnology company developing innovative, first-in-class, multispecific targeted peptide conjugate therapies for solid tumors, reported its debut public scientific presentation on March 27, 2025, at the 4th Novel Conjugates Summit taking place in Boston, Massachusetts (Press release, TwoStep Therapeutics, MAR 19, 2025, View Source [SID1234651276]). This presentation will highlight the outstanding preclinical efficacy and safety of its lead tumor-targeted drug conjugate program, along with a first look at their new radiopharmaceutical program.

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Oral Presentation:
Title: Overcoming Tumor Heterogeneity via Multispecific Targeting
Date and Time: Thursday, March 27, 2025, at 9:00 a.m. ET
Invited Speaker: Caitlyn Miller, PhD, Co-Founder & CEO of TwoStep Therapeutics

TwoStep Therapeutics is a Stanford University spin-out launched in 2024, co-founded by Nobel Prize winner Carolyn Bertozzi, Jennifer Cochran, Ron Levy, and Caitlyn Miller, with seed investment of $8.7M to date.

"The company has made tremendous progress since our launch, and we’re excited to share our advancements at this summit," said Caitlyn Miller, CEO of TwoStep Therapeutics. "This event provides an excellent opportunity to highlight our innovative research and explore potential partnerships to further our mission of developing effective cancer therapies."

On March 19, 2025 Mindpeak reported collaboration that aims to assess the transformative potential of AI in digital pathology, with a specific focus on accelerating primary breast cancer diagnosis (Press release, AstraZeneca, MAR 19, 2025, View Source [SID1234651275]). Breast cancer remains one of the leading causes of cancer-related deaths in women worldwide.

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Early and accurate diagnosis is essential for significantly improving clinical outcomes and patient survival rates. However, this process is often hindered by a limited pathology workforce and time-consuming case prioritization. To address these challenges and improve primary breast cancer diagnosis, Mindpeak and AstraZeneca have launched an observational study aimed at understanding the potential of Mindpeak Breast H&E solution.

Mindpeak’s Breast H&E solution, utilized in the study, is an AI-powered software designed to analyze H&E-stained images of breast cancer patient samples. It evaluates the presence of invasive breast cancer as well as ductal carcinoma in situ (DCIS).

A multi-site validation study of Mindpeak’s Breast H&E solution involves a cohort of 900 H&E slides from suspected breast cancer cases.

Key Objectives of the Study:

Assessing Current Practices: Gaining insights into existing breast cancer pathology workflows in different regions and identifying areas for improvement.
Evaluating AI-Powered Tools: Studying the benefits of integrating AI solutions into pathology workflows to streamline primary breast cancer diagnosis, improve efficiency, and facilitate early treatment interventions.
Analyzing Diagnostic Accuracy: Validating the performance of computational pathology algorithms to support pathologists in primary cancer diagnosis.
"The collaboration with Mindpeak underscores our commitment to transforming care by improving diagnosis speed and accuracy," said Susan McCutcheon, International Medical Head of Oncology of AstraZeneca. "Innovative technologies like this have the potential to address critical global health challenges by optimizing diagnostic workflows for breast cancer patients and, ultimately, improving patient care and outcomes."

"We are thrilled to partner with AstraZeneca to further validate this groundbreaking technology," said Felix Faber, CEO of Mindpeak. "Integrating Mindpeak’s H&E solution into pathology workflows as a screening and diagnostic-support tool could make treatment decisions faster and more precise, holding the potential to improve primary breast cancer patient outcomes worldwide."

The companies hope that the study findings will help bridge diagnostic gaps and improve healthcare outcomes in areas with limited resources worldwide.

On March 19, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported a presentation of a new pre-clinical clinical data abstract at the upcoming Society of Surgical Oncology (SSO) 2025 Annual Meeting (Press release, Renovorx, MAR 19, 2025, View Source [SID1234651274]).

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The abstract, titled "Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial," is co-authored by Dr. Ramtin Agah, RenovoRx’s Chief Medical Officer. The abstract supports RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform via additional human PK data and pre-clinical data.

TAMP is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to locoregional treatment offers the potential for increased safety, tolerance, and improved efficacy.

RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial is evaluating the Company’s novel investigational drug-device combination product candidate, (intra-arterial delivery of gemcitabine via RenovoCath) known as IAG, utilizing the TAMP drug delivery platform in patients with Locally Advanced Pancreatic Cancer (LAPC). RenovoRx currently anticipates the completion of both patient enrollment and the second interim analysis for TIGeR-PaC in mid-2025. This abstract is a sub-study of the TIGeR-PaC clinical trial. The combination product candidate (IAG), which is enabled by the FDA-cleared RenovoCath device, is currently under investigation and has not been approved for commercial sale.

SSO 2025 Abstract Details:

Title: Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial
Authors: Emmanuel Zervos MD, Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD
Location: ePoster P379 at Tampa Convention Center, Tampa, FL
Dates: March 27 – 29, 2025
About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of LAPC. RenovoRx’s first investigational drug-device combination product candidate (intra-arterial delivery of gemcitabine via RenovoCath, known as IAG) using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy, gemcitabine.

The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study is investigating TAMP in LAPC. The study’s primary endpoint is an overall survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event (i.e., patient death), which is estimated to occur in the second quarter of 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in mid-2025.

On March 19, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that the United States Adopted Names (USAN) Council has approved "ateganosine" as the nonproprietary (generic) name for its lead molecule THIO, a telomere-targeting anticancer agent in clinical development as a first-in-class treatment for advanced non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, MAR 19, 2025, View Source [SID1234651273]).

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The USAN Council is responsible for selecting standardized, informative and unique nonproprietary (generic) drug names. It is made up of experts from the American Medical Association (AMA), the U.S. Pharmacopeial Convention (USP) and the U.S Food and Drug Administration (FDA).

"The designation of a new nonproprietary name for THIO is a key step along our development and regulatory pathway as we move forward with Phase 2 and 3 clinical trials," said Vlad Vitoc, M.D., CEO of MAIA. "We chose a name inspired by the mechanism of action of our molecule: altering telomeric guanosine of the cancer cells. The generic name ateganosine is a unique and consistent identity that will support clear communication between healthcare providers, patients and researchers."

Generic drug names are used in product information, drug regulation, labelling and prescribing as for promotional materials and scientific literature.

MAIA will retain the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.